Note: Descriptions are shown in the official language in which they were submitted.
CA 02751123 2012-11-30
LOW ODOR, HARD SURFACE SPORICIDES
AND CHEMICAL DECONTAMINANTS
[0001] [Intentionally blank]
FIELD OF THE INVENTION
[0002] This invention is directed to a low odor, liquid
decontamination/disinfectant
composition comprising multiple components, which, upon mixing, provide an
aqueous solution comprising low levels of peracetic acid for use in
decontaminating
articles and surfaces contaminated with bacteria, viruses, fungi, and other
chemical
or biological contaminants or warfare agents, including, but not limited to,
spores
such as Clostridium difficile (C.diff), Clostridium sporo genes and anthrax,
mouse
parvo virus, and mustard, nerve and other chemical and biological warfare
agents.
The inventive compositions are prepared just prior to use by combining two or
more
separately packaged components.
BACKGROUND OF THE INVENTION
[0003] Recently, there has been a high interest in environmental sporicides
due to
threats posed by, among other things, anthrax as a biological warfare agent,
C.diff.
epidemics in hospitals, and mouse parvo virus in animal labs. There is
significant
interest in the critical environment markets, such as hospitals, laboratories,
clinics,
and research and manufacturing facilities, for a product with improved
sporicidal
efficacy that can be used to disinfect, sterilize and decontaminate hard
surfaces.
There is also significant interest in cleaning and decontaminating surfaces
contaminated with chemical and other biological warfare agents in a wide
variety of
settings.
CA 02751123 2011-07-29
WO 2011/008225
PCT/US2010/000332
[0004] Hospital-acquired infections linked to exposure to C.diff spores are
a
universal health-care crisis. Infection with C.diff is life-threatening to
many patient
populations, and contamination of equipment, materials, and surfaces with
spores
produced by C.diff bacteria occurs frequently, despite the best efforts at
infection
control. Part of the reason is that C.diff spores can survive on surfaces for
long
periods and are inherently difficult to destroy. Diligent efforts are
necessary to
eradicate the spores and require the use of disinfectant cleaning compositions
with
efficacy against spores and bacteria that produce them.
[0005] Similarly, in the pharmaceutical industry, manufacturing facilities
have
experienced a number of product recalls and plant shutdowns due to
contamination
with bacteria, viruses, fungi, spores (including spore-forming bacteria) and
other
biological contaminants. There has been an increase in the use of disinfectant
sterilant products for cleaning pharmaceutical manufacturing equipment and
surfaces.
[0006] The main products used in the cleaning and disinfection of surfaces
contaminated with biological materials, specifically spores, are predominately
oxidizing compositions, such as liquid or granular hypochlorite solutions
(bleach), or
hydrogen peroxide-based products such as East DeconTM developed by Sandia
National Laboratories. Specific to C.diff, the standard practice in most
health care
institutions is to use a product based upon sodium hypochlorite, also known as
bleach. Hypochlorite-based disinfectants have been used with some success for
surface disinfection in those patient-care areas where surveillance and
epidemiology
indicate ongoing transmission of C.diff. At present, there are no EPA-
registered
products with specific claims for inactivating C.diff spores, but there are a
number of
registered products that contain hypochlorite. As discussed below, while
achieving
efficacy in eradication of spores, use of currently available "bleach"
products has
many drawbacks.
[0007] Products used in the pharmaceutical manufacturing industry to
eradicate
spores and spore-forming bacteria rely on oxidizing chemistries, one of which
is
hydrogen peroxide. Like the use of hypochlorite-based products in health care
2
CA 02751123 2011-07-29
WO 2011/008225
PCT/US2010/000332
institutions, the use of hydrogen peroxide chemistries for bacterial
eradication in the
pharmaceutical industry also suffers from many disadvantages.
[0008] Many sporicide products are available commercially. In
addition to
hypochlorite and hydrogen peroxide, products containing alcohols, peracetic
acid
(PAA), peracetic acid in combination with alcohols, hypochlorite or peroxide,
and
various products that utilize peroxygen sources and acetyl donors to generate
both
peracetic acid and hydrogen peroxide, are available as disinfectants or
sterilants.
These commercially available products, while effective in part, have some
disadvantages.
[0009] Many of these products have aesthetic and handling disadvantages,
such
as harshness (acidity or alkalinity), strong odor, and skin and mucous
membrane
irritation, due to high concentrations of active components. Most currently
available
products require overly cumbersome personal protective equipment to be used
during their application to limit exposure, thus adding to their costs. The
use, storage
and transportation of these known, decontamination products thus present
significant
physical and health hazards and logistical challenges in shipping, handling
and
storage.
[0010] In particular with regard to spores, alcohol-based disinfectants,
alone, are
not effective against C.diff or other spores, or spore-forming bacteria. Nor
is liquid
hydrogen peroxide alone effective against spores or other biological
contaminants
without additives to boost its reactivity.
[0011] Hypochlorite bleach, although efficacious against C.diff, is not
without the
aforenoted disadvantages. In addition, sodium hypochlorite has poor materials
compatibility. Most sodium hypochlorite products are alkaline in nature and
are
corrosive to many materials, such as stainless steel, brass and copper. In
addition, it
has been shown that sodium hypochlorite can "strip away" waxes commonly used
on
hospital surfaces, making it an impractical choice for mopping applications.
Further,
sodium hypochlorite is associated with a difficult-to-rinse residue, which may
contribute to its "stripping" effect. Finally, sodium hypochlorite
demonstrates only
3
CA 02751123 2011-07-29
WO 2011/008225
PCT/US2010/000332
moderate efficacy against certain organisms. It degrades rapidly in the
presence of
an organic soil load, thus negatively impacting its efficacy.
[0012] Handling requirements also need to be considered. Oxidizing
chemistries,
such as bleach and hydrogen peroxide formulations, are also known to be harsh
chemistries requiring specific handling requirements. Depending on
concentration,
hydrogen peroxide may be subject to stringent handling restrictions. It may
also be
associated with strong odors and inhalation irritation issues. The OSHA
permissible
exposure limit (PEL) is 1 ppm for hydrogen peroxide. Some combination
products,
containing hydrogen peroxide as one component, may still be subject to air
shipment
restrictions based upon the concentration of hydrogen peroxide. In most cases,
the
products need to be shipped either by ground or sea causing delays in their
arrival at
required locations. Air shipment is possible for hydrogen peroxide, but
quantities are
severely limited and require special packaging.
[0013] Both sodium hypochlorite and hydrogen peroxide in high
concentrations
are corrosive to metal substrates, require special packaging, have limited
transportation modalities and unstable without controlled transportation
systems.
Storage is also problematic. The storage of large amounts of highly corrosive
and
heat sensitive liquids is a safety issue. Bleach (hypochlorite) decomposes
quickly at
high temperatures resulting in a significant loss of efficacy and, therefore,
has limited
shelf life. Hydrogen peroxide spontaneously and irreversibly decomposes at
elevated temperatures. Both hypochlorite- and hydrogen peroxide¨based
materials
will also decompose rapidly when subjected to environmental contaminants such
as
dirt or blowing sand.
[0014] It is further noted that in addition to metal substrates, bleach and
hydrogen
peroxide are incompatible with a number of non-metal substrates such as
paints, soft
metals, rubbers and plastics.
[0015] Similarly, peracetic acid can achieve a high level of
decontamination,
disinfection and sterilization against both biological and chemical
contaminants;
however, concentrated solutions of peracetic acid are corrosive and are strong
4
CA 02751123 2011-07-29
WO 2011/008225
PCT/US2010/000332
oxidizers. Strong oxidizers are expensive to ship and handle. They also
present a
safety hazard for customers in use, as well as during packaging. Typically,
liquid
peracetic acid is extremely unstable and must be separated from the rest of
the
formula in the product package. Even with separate packaging, products
containing
peracetic acid tend to have a limited shelf life.
[0016] Generating peracetic acid in situ from a solid acetyl donor may
solve
certain shipping, handling and stability problems. Typically, in systems that
generate
peracetic acid in situ, the peroxide source is also a solid persalt, such as
sodium
percarbonate or sodium perborate. While these products have longer shelf life
and a
good safety profile, they are often cumbersome to dissolve and require
extended
periods of time to generate effective concentrations of peracetic acid. Due to
the
typically high solids content of the resulting solutions of these products,
there is the
potential of leaving substantial residues on surfaces. These residues need to
be
rinsed or wiped from the surface. This is a particular disadvantage with
respect to
chemical and biological warfare agent decontamination, which is likely to be
encountered in situations and areas where adequate rinse water supply is not
readily
available.
[0017] Finally, another disadvantage of most commercially available
hydrogen
peroxide and peracetic acid systems is that they cannot be sold as sterile. In
order to
create sterile products, the systems must be capable of being sterilized with
gamma-
irradiation. Gamma irradiation is commonly used in the pharmaceutical industry
to
sterilize cleaning compositions. Most commercial peracetic acid and hydrogen
peroxide systems are not stable when exposed to gamma-irradiation and cannot
be
sterilized in this manner, requiring additional sterilization steps, if a
sterile product is
needed, adding to the costs associated with their use.
[0018] Accordingly, in the health care market and the pharmaceutical
industry, an
effective sporicide with EPA-approved claims against C.diff is needed to
address the
emerging health care and product contamination issues. C.diff spores can live
on
surfaces for years. C.diff spores are very difficult to kill. As mentioned
above,
sporicide products are available, but most have safety, odor, material
compatibility
CA 02751123 2011-07-29
WO 2011/008225
PCT/US2010/000332
and handling issues, among others. Currently, there are no EPA-approved
products
to address C.diff spores. The current practice in most health care
institutions is to
use a 10% solution of hypochlorite to clean all articles presumed to be
contaminated
with C.diff spores. There is a need, therefore, for a product having lower
odor, better
materials compatibility, improved safety profile, less stringent shipping
requirements,
and less onerous handling and storage parameters than currently existing
products.
[0019] Formulations comprising peracetic acid, or components capable of
generating peracetic acid (PAA) in situ, are effective sporicides and are
nearly
equivalent to acidified bleach, an industry standard for efficacy against
spores. A
new sporicide system for each of the above-discussed markets (health care and
pharmaceutical manufacturing) has been developed, having unexpected efficacy
against spores and spore-forming bacteria, such as C.diff, as well as other
bacteria,
virus, or fungi, but without the disadvantages of currently available
products. The
new inventive systems comprise formulations that also have excellent activity
in
decontaminating surfaces exposed to chemical and biological warfare agents.
Different embodiments of these inventive systems may be used depending on the
needs of the market served; however, the foundation of the chemistry is the
same:
generation of peracetic acid through the perhydrolysis of an acetyl donor,
such as
tetraacetylethylenediamine (TAED) or diacetylmethylamine (DAMA) in combination
with a hydrogen peroxide solution.
[0020] Product formulations containing peracetic and/or components for
generating peracetic acid are known in the art. Peracetic acid is supplied
typically as
a concentrated or diluted solution, or is generated in situ from an acetyl
donor and a
peroxide source. Systems comprising dry components exist that utilize solid
peroxygen sources and acetyl donors, which, when mixed with water, produce
peracetic acid (PAA). (See e.g., U.S. Patent No. 5,350,563, directed to a two-
part
perborate/acetyl donor powdered formulation.) While dry product forms have
application in certain cases and have an advantage of a longer shelf life and
good
safety profile, they are generally limited by slow generation of PAA at room
temperature and, therefore, there is a preference for more rapid acting liquid
products
6
CA 02751123 2012-11-30
in certain applications. Use of dry peroxygen components is disadvantageous
due to
the time needed to generate hydrogen peroxide before activation (combination)
with
the acetyl donor. A particular disadvantage to multi-component dry systems is
that
the components dissolve very slowly in water, such that the desired
concentration of
active ingredients is not fully available until later stages. There is also an
additional
risk that undissolved components will remain and not be rinsed away. On the
other
hand, a system or formulation utilizing a liquid hydrogen peroxide component
has
been found to generate PAA much faster as the perhydroxyl ion is available
immediately upon combination with an acetyl donor, regardless of whether the
acetyl
donor is in solid or liquid form.
[0021] Other liquid commercial products containing both peracetic acid and
hydrogen peroxide are also known. For example, a liquid product produced by
Decon Labs, known as "SporGon comprises 7.35% hydrogen peroxide and 0.23%
peracetic acid; however, the high level of hydrogen peroxide in use requires a
limitation of exposure. OSHA limits personal hydrogen peroxide exposure to 1
ppm.
In addition, the product requires at least three hours to achieve
sterilization. Another
-31-
example is Oxonia Active, an acidic liquid sanitizer, produced by Ecolab. This
product is highly corrosive and has a hydrogen peroxide level of 27.5% and
peracetic
acid level of 5.8%. The high level of hydrogen peroxide requires, in addition
to
exposure limits, stringent shipping and handling requirements. In most
instances,
these products cannot be gamma-irradiated, the preferred method for
sterilization of
pharmaceutical industry disinfectants.
[0022] Liquid systems for generating PAA are also known. By way of example,
U.S. Patent Nos. 6,514,509 and 7,235,252 are directed to systems for preparing
organic peroxy acids using a parent solution and activator and requiring a
hydroalcoholic environment (at least 10% alcohol) with an acid pH. The alcohol
purportedly acts as an additional germicide. In contrast, the present
invention does
not utilize or require a hydroalcoholic environment and does not utilize
strong
inorganic acids to maintain an acid pH. Importantly, peracetic acid is
generated in an
alkaline environment, not acidic, and the resulting product rapidly converts
to a
* trade-mark 7
CA 02751123 2011-07-29
WO 2011/008225
PCT/US2010/000332
neutral pH upon peracetic acid generation. There is no need for an additional
germicide.
[0023] European Patent 0 598 170 B1 is a cleaning composition based on
hydrogen peroxide (or a peroxygen source) combined with acetyl triethyl
citrate as a
bleach activator. The bleach activator requires emulsification with at least
two
surfactants having different HLB values. The components are all combined in
one
unitary liquid composition.
[0024] The present invention is based upon combining an acetyl donor,
alkalinity
agents and a liquid hydrogen peroxide source to produce an effective
concentration
of peracetic acid in situ to destroy C.diff spores. The components of the
present
invention are separately packaged and, thus, the formulation is "ready-to-use"
upon
activation (combination of ingredients) and requires no further dilution or
manipulation
of components. Generation of peracetic acid is much faster due to the
immediate
availability of the perhydroxyl ion, as liquid hydrogen peroxide, as compared
to
products using a dry peroxygen source. Surprisingly, the present formulations
are
effective at much lower concentrations of peracetic acid than currently
available
products.
[0025] The present invention provides sporicidal formulations having a pH
in the
neutral range (4-8), which allows for easier disposal versus highly alkaline
or acidic
products, and has superior materials compatibility against soft metals,
plastics, resins
and other materials, as compared to bleach. The inventive formulations also
result in
low odor products that are less caustic or irritating to personnel than
existing
products, including those containing higher levels of peracetic acid, and may
eliminate the need for respiratory protection required for application of
higher
concentrations of FAA and acidified bleach. They have no detectable levels of
acetic
acid or hydrogen peroxide. Most commercially available FAA-containing products
require the use of acetic acid to stabilize the peracetic acid for longer
shelf life,
greatly increasing the odor profile. Since peracetic acid is generated in situ
with the
present invention, there is no need for the addition of acetic acid or any
other acid,
thus reducing or eliminating the odor profile.
8
CA 02751123 2011-07-29
WO 2011/008225
PCT/US2010/000332
[0026] The present invention also provides for no-rinse decontamination,
thus
allowing for an effective decontamination where rinse water is not readily
available
and/or reducing the amount of water required for standard decontamination by
about
50%. This is especially advantageous in decontamination of chemical and
biological
warfare agents, which may be encountered in a wide variety of environments.
[0027] Unexpectedly, the formulations of the present inventions are
efficacious
against a wide range of bacteria, viruses, fungi and spores, including C.diff,
as well
as against several chemical and biological warfare agents, without the
addition of
additional decontaminants, disinfectants, biocides or germicides and, hence,
are less
costly. Microbial efficacy has been shown even in the presence of an organic
soil
load and at a lower concentration of peracetic acid. Surfactants utilized in
the
present system are excellent cleaners, improving efficacy in the presence of
an
organic soil. Finally, the inventive formulations comprise low levels of
hydrogen
peroxide, which is not subject to stringent shipping and handling
requirements.
[0028] Other advantages of the present invention include increased shelf
life of
peracetic acid-based disinfectants, improved dissolution and mixing time, and
increased pot life.
[0029] Tetraacetylethylenediamine (TAED) is the preferred acetyl donor for
the
present invention; however, diacetylmethylamine (DAMA) also yields comparable
results and, indeed, may be preferred in chemical and biological warfare agent
decontamination. Hydrogen peroxide is the chosen perhydroxyl source. Hydrogen
peroxide may be used either as a formulation comprising hydrogen peroxide,
surfactants and fragrance, or alternatively, as a plain aqueous solution. Both
TAED
and hydrogen peroxide are currently registered EPA-active ingredients. DAMA is
not
an EPA registered active ingredient, but is available in a clear liquid form
at room
temperature and provides rapid PAA generation and immediately clear, low-
residue
end-use solutions.
9
CA 02751123 2011-07-29
WO 2011/008225
PCT/US2010/000332
[0030] While several different embodiments are contemplated for the
inventive
formulations, they all share the advantageous properties of preparation at a
neutral
pH, low odor, better materials compatibility, improved safety profile and high
efficacy.
[0031] In one embodiment, a two-part system comprises a solid, dry TAED
powder activator and a formulated hydrogen peroxide solution comprising
hydrogen
peroxide, a surfactant and a fragrance.
[0032] In another embodiment, a three-part liquid system comprises first, a
two ¨
part liquid TAED activator (comprising in two parts, a separate TAED
suspension and
a separate alkaline liquid solution) and, as the third part, the same
formulated
hydrogen peroxide as used in the two-part system above.
[0033] In yet another embodiment, a two-part liquid system comprises a
first
solution containing an acetyl donor (in liquid form or combined with a
solvent) and a
second solution comprising aqueous hydrogen peroxide. An amine alkalinity
source
could be a third component or be included with the acetyl donor portion in
this
embodiment.
[0034] All embodiments, upon activation (combination), generate lower
levels of
peracetic acid with unexpected anti-microbial and decontaminating efficacy.
[0035] It is an object of this invention to provide a low odor disinfectant
having
efficacy against bacteria, viruses, fungi and other biological materials,
including
spores and spore-forming bacteria, such as C. diff, as well as chemical and
biological
warfare agents.
[0036] It is a further object of this invention to provide a low-odor
peracetic acid
solution with greatly improved safety and handling features over currently
available
products.
[0037] Still a further object of this invention is to provide a system for
rapid
generation of peracetic acid in an alkaline pH environment, which quickly
drops into
the neutral range upon peracetic acid generation, resulting in a product that
is usable
CA 02751123 2011-07-29
WO 2011/008225
PCT/US2010/000332
within a short period of time after combination and having a use life of at
least 24
hours.
[0038] Yet a further object of this invention is to provide a peracetic
acid solution
which has efficacy even in the presence of an organic soil load.
[0039] It is a further object of this invention to provide an effective,
safer
alternative to hypochlorite or other oxidizing chemistries for use in health
care
environments to eradicate C. duff spores.
[0040] Finally, it is an object of this invention to provide a "no rinse"
peracetic acid
cleaner and/or a peracetic acid that requires no, or less, rinse water for
removal as
compared to conventional products currently available.
[0041] These and other objects of the invention will be apparent based upon
the
description herein.
SUMMARY OF THE INVENTION
[0042] The invention is directed to a low-odor sporicide/decontaminant
based
upon the generation of peracetic acid from an acetyl donor combined with
liquid
hydrogen peroxide. The peracetic acid is generated in an alkaline environment,
and
the final product has a neutral pH, making it safer and easier to handle and
transport.
The liquid hydrogen peroxide component allows for rapid generation of
peracetic acid
compared to conventional products based upon dry peroxygen sources.
Surprisingly,
the low levels of peracetic acid generated are effective against bacteria,
viruses,
fungi and other microbes, including spore formers, such as C.diff, as well as
chemical or biological warfare agents, without the need for high
concentrations of
peracetic acid or the addition of other disinfectant or sterilizing agents.
[0043] In one embodiment, the inventive composition comprises:
a) a solid activator blend comprising a solid acetyl donor combined with a
solid alkalinity source; and
b) a hydrogen peroxide solution,
11
CA 02751123 2011-07-29
WO 2011/008225
PCT/US2010/000332
wherein the solid activator blend is mixed with the hydrogen peroxide solution
just prior to use to form a peracetic acid solution.
[0044] In a second embodiment, the inventive composition comprises:
a) a two-part liquid activator comprising in one part, an acetyl donor
dispersion, and in the other part, an alkaline solution; and
b) a hydrogen peroxide solution,
wherein the acetyl donor dispersion and alkaline solution are mixed with the
hydrogen peroxide solution just prior to use to form peracetic acid.
[0045] In a third embodiment, the inventive composition comprises:
a) a liquid comprising an acetyl donor in a solvent;
b) a hydrogen peroxide solution;
C) an alkalinity source as a third component, or as a part of the
acetyl
donor liquid to catalyze a peracetic acid generating reaction, and
d) optionally, a surfactant;
wherein the acetyl donor containing liquid is mixed with the hydrogen peroxide
solution just prior to use and reacts to form a peracetic acid solution.
[0046] In some embodiments, the hydrogen peroxide solution may be
formulated
with a surfactant, fragrance, and water. Alternatively, a dilute, aqueous
solution of
hydrogen peroxide may be used. Optionally, surfactants may be contained within
the
acetyl donor component.
[0047] In all embodiments, hydrogen peroxide is used in very low amounts,
preferably less than 8 to about 10 weight percent, more preferably less than 3
weight
percent, and most preferably less than 1.5 weight percent. The lower
concentration
of hydrogen peroxide avoids shipping and handling restrictions and is safer
for use.
Once mixed, the hydrogen peroxide content remains close to the original low
levels
that were present prior to mixing.
12
CA 02751123 2011-07-29
WO 2011/008225 PCT/US2010/000332
[0048] The concentration of peracetic acid produced can vary depending on the
amounts of activator (acetyl donor portion) and hydrogen peroxide solution
that are
combined.
BRIEF DESCRIPTION OF THE DRAWINGS
[0049] The invention will be better understood and other features and
advantages
will become apparent by reading the detailed description of the invention,
taken
together with the drawings, wherein:
FIG. 1 is a graph which depicts superior sporicidal efficacy against Bacillus
subtilis (in a modified Non-Food Contact Sanitizer Study) of the inventive
formulation
of approximately 0.25% peracetic acid as compared to a 1:10 dilution of bleach
in
water, in the presence of various organic loads and contact times of 2, 5, 10
and 20
minutes.
FIG. 2 is a bar graph which shows the effect of varying concentrations of
peracetic acid (PAA) against C. difficile spores in a Quantitative Carrier
Test 2 (QCT-
2) for a three minute contact time.
FIG. 3 is a bar graph which shows the effect of soil load on the inventive
formulations versus a 10% bleach solution against C. difficile spores.
FIG. 4 is a graph which demonstrates the generation of peracetic acid from
diacetylmethylamide, hydrogen peroxide, and ammonium hydroxide at three
concentration levels monitored over time.
FIG. 5 is a bar graph comparing the hard surface biological efficacy of an
inventive formulation as compared to 10% bleach.
FIG. 6 is a bar graph comparing the biological efficacy of inventive
formulations to a commercially available sporicide, wherein the inventive
formulations
demonstrated superior efficacy.
FIG. 7 is a bar graph showing equal efficacy of an inventive formulation
against different types of spores.
13
CA 02751123 2012-11-30
=
DETAILED DESCRIPTION OF THE INVENTION
[0050] The general chemistry that forms the base of the claimed compositions
is
peracetic acid, generated from the combination of an acetyl donor, such as
TAED or
DAMA, and hydrogen peroxide at an alkaline pH, as the source of antimicrobial
efficacy, Both TAED and hydrogen peroxide are recognized by the EPA as active
ingredients. DAMA is not. The claimed compositions utilize components that are
kept separate until such time as the disinfectant solution is needed. Once
mixed, the
compositions have a use life of about 24 hours. Typically, the claimed
compositions
generate from about 0.05 to about 0.25% peracetic acid solutions, but
concentrations
may vary depending on the amount of acetyl donor utilized and may range up to
about 2.5%.
[00511 As one component, the inventive compositions comprise an acetyl
donor,
such as TAED or DAMA. Typical acetyl donors would be of the form presented in
Formula 1 below.
R3
0 __________________ /
Formula 1. Basic structure of the acetyl donor.
N R1
wherein R1, R2 and R3 could be any group which would not interfere with the
generation of peracetic acid, would not be oxidized in the system, and would
allow for
the dissolution of the acetyl donor.
[0052] In a first embodiment, the activator is in solid powder or "dry"
form. TAED
is the preferred acetyl donor. Solid TAED is first coated with a surfactant or
blend of
surfactants to aid in dissolution upon activation. The surfactant used to coat
the
TAED is typically anionic, although the claimed compositions are not limited
to
anionic surfactants. One useful surfactant is alkyldiphenyl oxide disulfonate,
sold as
an aqueous 45% active solution under the nameDowfaX C10-L. Other anionic
* trade-mark
14
CA 02751123 2012-11-30
surfactants useful in the present invention include N-oleoyl sarcosinate and
dodecylbenzene sulfonic acid.
[0053] The surfactant is applied to the TAED as an aqueous solution,
wherein the
TAED, traditionally water insoluble, is mixed into a slurry. The slurry is
then dried,
and the resulting "cake" is pulverized into a powder, which is comprised of
TAED
coated with a surfactant. This "coated" TAED is then blended with two dry
alkalinity
sources. The complete blend of the "coated" TAED with the dry alkalinity
sources
comprises the dry "activator" portion of the composition. In this embodiment,
the
alkalinity sources for the powdered, coated TAED include sodium carbonate and
a
biodegradable chelating agent such as the tetrasodium salt of iminodisuccinic
acid
(sold under the trade name t aypure*CX 100). Advantageously, the
iminodisuccinic
acid also acts as a chelating agent which aids in the efficacy of the system
in the
presence of an organic load.
[0054] At the time of, or just prior to, use, the dry "activator" is
combined with a
formulated hydrogen peroxide solution, which contains hydrogen peroxide and a
surfactant or blend of surfactants. A formulation of liquid hydrogen peroxide
is
preferred over a dry perhydroxyl or peroxygen source due to much faster
generation
of peracetic acid achieved upon combination of the liquid hydrogen peroxide
with the
TAED activator. When combined (or "activated"), peracetic acid is generated.
Depending on the amounts of activator and hydrogen peroxide selected, various
concentrations of peracetic acid may be generated. Upon activation, the
product,
regardless of PAA concentration, will have a 24-hour pot-life (i.e., "shelf"
or "use-
dilution" life).
[0055] In a second embodiment, the acetyl donor, i.e., "TAED activator", is
itself a
two-part liquid activator system. As one part of the liquid activator, a TAED
dispersion is prepared. TAED is suspended in an aqueous system that includes a
suspending agent, and perhaps surfactants and solvents. Typical suspending
agents
include magnesium aluminum silicate and Xanthan gum. The second part of the
liquid activator is an alkaline, aqueous solution comprising an alkalinity
source and
surfactant(s). The alkalinity source can be a hydroxide, amine or chelating
agent, or
* trade¨mark
CA 02751123 2012-11-30
combinations thereof. Typical examples include sodium hydroxide, monoethanol-
amine, triethanolamine, 2-amino-2-methyl-1-propanol, and other amines.
[0058] For the embodiment utilizing a two-part liquid TAED activator,
anionic or
nonionic surfactants may be used. Typical anionic surfactants include N-oleoyl
sarcosinate, alkyldiphenyloxide disulfonate, and dodecylbenzene sulfonic acid.
A
typical nonionic surfactant is polymethylene sorbitan monolaurate. Other
useful
surfactants are known to those skilled in the art.
[0057] Each part of the "two-part liquid TAED activator" system is kept
physically
separated (through packaging). Just prior to use, both parts are added to the
formulated hydrogen peroxide solution, and peracetic acid is generated. The
concentration of peracetic acid generated depends on the quantities of
activator and
hydrogen peroxide selected. Again, this product, upon activation, will have a
24-hour
pot-life.
[0058] In both the first and second embodiments, the "activator" portions
(dry,
coated TAED in the first embodiment or two-part liquid TAED/alkaline solution
in the
second embodiment) are mixed with a specifically-formulated liquid hydrogen
peroxide solution, which contains a surfactant to aid both in wetting of the
product in
use and controlling the foam profile on activation. Useful surfactants for the
hydrogen peroxide solution can be anionic, nonionic or amphoteric in nature.
Typical
examples are sodium lauryl sulfate, sodium octyl sulfate,bowfaX4C10-L,
andEPluronio*
F-127. Other useful surfactants are known to those skilled in the art.
Generally, non-
foaming or low-foaming surfactants are preferred. The hydrogen peroxide
solution
may also contain a fragrance to provide a pleasing odor, The amount of
hydrogen
peroxide in the formulation may be as high as 10%; however, optimally it is
less than
about 8% but greater than 0.1%, and most preferably less than 5% but greater
than
0.50%.
[0059] The pH of the hydrogen peroxide solution is about 4.5, and the pH of
the
inventive composition is neutral (4-8).
* trade-mark
16
CA 02751123 2012-11-30
[0060] In a third embodiment, DAMA is the preferred acetyl donor, although
TAED
has been shown to be effective. A first part or portion comprising DAMA, an
optional
surfactant and a solvent is prepared as a separate solution. This first part
is mixed
with a hydrogen peroxide solution at the time of use. An amine alkalinity
source is
added as either a third component or included in the acetyl donor (first)
solution. If
liquid DAMA is used, the solvent may be omitted.
[0061] The components are packaged separately and mixed by the consumer just
prior to use. The result of mixing is rapid generation of peracetic acid in
situ
according to the reaction scheme shown in Formula 2 below:
o\ H30-(
\R. NH- CH3
R¨N/
N¨CH3 H3C
4 r 4
H3c4 HQ\ 0 HO
R'
0 0
[0062] The solvent and surfactants, when used, act as wetting and cleaning
agents on hard surfaces. The solvent also aids in the dissolution of chemical
warfare
agents and increases the evaporation rate from surfaces. The peracetic acid
resulting from the reaction is capable of rapidly disinfecting and
decontaminating
surfaces. After application to the surface, the solution evaporates from the
surface
with very little residue and does not need to be rinsed.
[0063] Other known acetyl donors useful in the inventive compositions may
include *Aspirin* (acetylsalicylic acid), n-methyl diacetamide, and triacetin;
however,
TAED and DAMA are preferred.
[0064] TAED is present in the dry activator portion of the first embodiment
in
amounts ranging from about 40 to about 75 weight percent, based upon the
weight of
the dry activator component. TAED is present in the TAED dispersion portion
(activator) of the second embodiment in amounts ranging from about 30 to about
40
weight percent, based upon the weight of the TAED dispersion. Generally, one
mole
of TAED generates two moles of peracetic acid, but the concentration of
peracetic
* trade-mark
17
CA 02751123 2012-11-30
acid generated will depend on the amounts of activator and hydrogen peroxide
that
are combined.
[0065] DAMA is present in the acetyl donor portion of the third embodiment
in
amounts ranging from about 0.5 to about 10 weight percent, based upon the
total
weight of the combined components (parts), i.e., use dilution.
[0066] Surfactants useful in the present inventions include alkyldiphenyl
oxide
disulfonate (Dowfax C10-L), N-oleoyl sarcosinate, dodecylbenzene sulfonic
acid,
sodium lauryl sarcosinate and tergitor L-62 (an ethylene oxide/propylene oxide
co-
polymer).
[0067] Surfactants that have a tendency to create excessive foam during
mixing
are less preferred over foam-reducing surfactants. Surfactants are important
in the
decontamination process for chemical agents, since they achieve the desired
solubility of the chemical agent without negative ramifications. Surfactants
also
improve wetting features and can reduce the appearance of residues on a
surface.
[0068] Surfactants are present in the "dry activator portion" of the first
embodiment in amounts ranging from about 5 to about 20 weight percent, based
on
the weight of the dry activator portion.
[0069] Surfactants are present in the TAED dispersion portion of the two-
part
liquid activator of the second embodiment in amounts ranging from about 0.5 to
about 5 weight percent, based upon the weight of the TAED dispersion.
Surfactants
are present in the alkaline solution portion of the two-part activator system
in
amounts ranging from about 0 to about 10 weight percent, based upon the weight
of
the alkaline solution.
[0070] Optional surfactants, if present in the third embodiment, range in
amounts
from about 0.03 to about 5 weight percent, based upon the total weight of the
combined components (parts), i.e., use dilution.
* trade-mark
18
CA 02751123 2011-07-29
WO 2011/008225
PCT/US2010/000332
[0071] Finally, surfactants may be present in the formulated hydrogen
peroxide
solution in amounts ranging from about 0.01 to about 2 weight percent, based
upon
the total weight of the formulated hydrogen peroxide solution.
[0072] Various alkalinity sources and buffers are also used in the claimed
compositions. Exemplary alkalinity sources for a "dry" TAED activator include
sodium carbonate. Glycolic acid is an example of a buffer for the TAED
dispersion.
These examples are not intended to be limiting, as buffers are known to those
skilled
in the art. lminodisuccinic acid derivatives are also useful as alkalinity
agents in both
the dry TAED activator and the two-part liquid TAED/alkaline solution
activator and
also function as chelating agent(s). 2-amino-2-methyl-1 propanol (AMP 95) also
serves as a useful alkalinity source and solvent.
[0073] The alkalinity source for the DAMA-based system preferably comprises a
primary, secondary or tertiary amine. Amine-based alkalinity sources act to
catalyze
the peracetic acid generating reaction. Requirements for the amine are a pKa
sufficiently high to catalyze the reaction and solubility in the system. The
selected
amine should also not be easily oxidized or contain groups that would inhibit
generation of peracetic acid or degrade the peracetic acid after generation.
Exemplary amines are listed below. Volatile amines are most preferred to
obtain "no-
rinse" formulations. The alkalinity source can be included in the acetyl donor
and
solvent portion or as a separate third component.
Example Alkalinity Sources for DAMA Based Formulations
Name CAS#
Anhydrous Ammonia 7664-41-7
Ammonium Hydroxide 1336-21-6
Triethylamine 121-44-8
Triethanolamine 102-71-6
2-Ethanolamine 141-43-5
2-(methylamino) ethanol 109-83-1
Diethanolamine 111-42-2
(R)-(-)-2-amino-l-butanol 5856-63-3
2-(tert-butylamino) ethanol 4620-70-6
2-(2-Aminoethylamino) ethanol 111-41-1
19
CA 02751123 2011-07-29
WO 2011/008225 PCT/US2010/000332
[0074] Biodegradable chelating agents are also useful as an alkalinity
source and
include, by way of example, the tetrasodium salt of iminodisuccinic acid.
Iminodisuccinic acid derivatives are preferred; however, other useful
chelating agents
include methylglycine diacetic acid (MGDA) and disodium ethylene diamine
tetraacetic acid (EDTA).
[0075] Solvents are also used in the inventive formulations. Useful
exemplary
solvents for the TAED dispersion portion of the two-part liquid activator
system
include PPG-2 methyl ether and AMP-95 (2-amino-2-methyl-1-propanol). Other
solvents useful with DAMA include isopropanol, ethyl lactate and Tergitol L-62
(also
useful as a surfactant). Alternatively, DAMA based formulations may omit the
solvent, if liquid DAMA is used.
[0076] The TAED dispersion typically includes a suspending agent such as
magnesium aluminum silicate or Xanthan gum; however, other suspending agents
known to those skilled in the art may be used.
[0077] All embodiments may further include adjuvants such as fragrances,
dyes,
colors or preservatives.
[0078] Table I below shows an exemplary formulation showing ranges for the
components of the first embodiment.
TABLE I - COMPONENTS
Dry TAED Activator
Raw Material Wt. % (range)
Tetraacetylethylenediamine (TAED) 50 ¨ 85
Dowfax C1OL (alkyldiphenyloxide disulfonate) 1 1 0 - 30
Baypure CX 100 (lminodisuccinic acid, 1 ¨ 15
Tetrasodium salt) 2
Sodium Carbonate 3 1 - 5
1 Dowfax C1OL is an anionic surfactant.
2 Baypure CX 100 is a chelating agent and alkalinity source.
3 Sodium carbonate is an alkalinity source
CA 02751123 2012-11-30
Formulated Hydrogen Peroxide Solution
Raw Material Wt. % (range)
Hydrogen Peroxide (35%) 1 ¨ 25
Deionized Water 70¨ 98
Poloxamer 407 4 0.01 - 1.0
Fragrance (Red Apple) 0.01 ¨ 1.0
pH 4.0 ¨ 5.5
4 Poloxamer 407 is a nonionic, PO/E0, block copolymer surfactant.
[0079] Table II below shows an exemplary formulation showing ranges for the
components of the second embodiment.
TABLE II
TAED Dispersion
Raw Material Wt. %
(range)
Tetraacetylethylenediamine (TAED) 30.4 - 40.0 _
Deionized Water 39 ¨ 69
Aluminum Magnesium (Suspending Agent) 1.0 ¨ 3.0
PPG-2 Mgthyl Ether (Solvent) 0¨ 10
,'PG-2
(oleolyl sarcosinate) (Anionic Surfactant) 0.5 ¨ 2.0
carbamato) (Preservative) 0 ¨ 0.5
_Glycolic Acid (pH adjuster / buffer) 0 ¨ 2.0
pH 3.5 ¨ 6.5
Alkaline Solution
Raw Material Wt. % (range)
AMP-95 (2-amino-2-methyl-1-propanol¶Alkalinity Source/Solvent) 4.20 ¨ 7.0
Dowfax Cl OL (alkyldiphenyloxide disulfonate) 0¨ 7.0
Baypure CX 100 (lminodisuccinic acid, Tetrasodium salt) 0.84 ¨4.2
Deionized Water 81.80 ¨94.96
pH 11 ¨ 12
Formulated Hydrogen Peroxide Solution
Raw Material Wt. % (range)
Hydrogen Peroxide (35%) 1 ¨ 25
Deionized Water 70¨ 98
Poloxamer 407 0.01 ¨ 1.0
Fragrance (Red Apple) " 0.01 ¨ 1.0
pH 4.0 ¨ 5.5
* trade¨mark
21
CA 02751123 2011-07-29
WO 2011/008225
PCT/US2010/000332
[0080] As discussed, the level concentration of peracetic acid generated
varies
depending on how much of the TAED activator is added to the hydrogen peroxide
formulation. As stated, one mole of TAED generates two moles of peracetic
acid.
Generally, activator is added in quantities such that hydrogen peroxide will
be in
excess.
[0081] As an example, in the first embodiment, dry TAED activator may be
combined with formulated hydrogen peroxide at the following ratio: 0.5-1.5
wt/wt of
dry activator to 98.5-99.5% formulated hydrogen peroxide solution. This
combination
yields approximately 0.25% peracetic acid. As an example of the second
embodiment, the TAED dispersion and alkaline solution are combined with the
formulated hydrogen peroxide in the following ratio: 1-2 wt/wt TAED =
dispersion; 1-2
wt/wt alkaline solution and 96-98% of formulated hydrogen peroxide solution.
This
combination also yields approximately 0.25% peracetic acid.
[0082] Tables III, IV and V below show exemplary formulations for the third
embodiment comprising DAMA as the acetyl donor source for biological and
chemical warfare agent testing. Table VI illustrates exemplary formulations
for
generating various concentrations of peracetic acid using DAMA as the acetyl
donor.
Concentrations of peracetic acid achieved are directly proportional to the
concentration of DAMA in solution, as illustrated below in Table VI. The
mixtures
consistently produce levels of peracetic acid that are approximately 80% of
what is
calculated as theoretical. FIG. 4 demonstrates this at three levels of
peracetic acid
(2,500 ppm, 5,000 ppm, and 10,000 ppm) expected to be found in decontaminant
products comprising DAMA, hydrogen peroxide and ammonium hydroxide.
TABLE Ill
Concentration of Ingredients in Sample Formulations
used in Biological Efficacy Testing
Ingredient A
DAMA 132 mM 132 mM 132 mM 66 mM
H202 (wt. %)* 9% 9% 9% 4.5%
NH4OH Amine 10 mM 10 mM 10 mM 5 mM
Solvent lsopropanol 30% Ethyl Lactate 30% Tergitol L-62 0.3% None
Water Balance Balance Balance Balance
* Concentrations of hydrogen peroxide are end use.
22
CA 02751123 2011-07-29
WO 2011/008225
PCT/US2010/000332
TABLE IV
Concentration of Ingredients in Sample Formulations
used in Chemical Efficacy Testing
Ingredient
DAMA 66 mM 66 mM 132 mM 132 mM 66
mM
H202 (wt. %)* 4.5% 4.5% 4.5% 4.5%
4.5%
Amine
NH4OH 5 mM NH4OH 5 mM NH4OH 10 mM Ethanolamine NH4OH 5 mM
6 mM
Solvent None lsopropanol Isopropanol
lsopropanol None
30% 30% 30%
Add
NaHCO3 0.1 M
Ingredients
Water Balance Balance Balance Balance Balance
* Concentrations of hydrogen peroxide are end use.
TABLE V
Concentration of Ingredients in Formulas Prepared
with Different Amine Alkalinity Sources
Ingredient
DAMA 66 mM 66 mM 66 mM
H202 (wt. %)* 4.5% 4.5% 4.5%
Amine 2-(methylamino) (R)-(-)-2-Amino-1- 2-
(tert-Butylamino)
ethanol 12.5 mM Butanol 10.6 mM Ethanol 7.4 mM
Water Balance Balance Balance
* Concentrations of hydrogen peroxide are end use.
TABLE VI
2.4% Peracetic Acid Generating Formulas
Alkalinity Source DAMA 7% H202 10% w/v
10% TEA 2.0 M NH3 H20
(mL) (mL) NH4OH (mL) in IPA
(mL)
(mL)
50 mM NH4OH 0.432 6.500 0.175
2.893
70 mM TEA 0.432 6.500 1.951
1.117
60 mM NH3 in 0.432 6.500 0.300
2.768
IPA
80 mM NH3 in 0.432 6.500 0.400
2.668
IPA
DAMA = diacetylmethylamine
TEA = triethylamine
IPA = isopropyl alcohol
23
CA 02751123 2011-07-29
WO 2011/008225
PCT/US2010/000332
1.2% Peracetic Acid Generating Formulas
Alkalinity Source DAMA 7% H202 10% w/v 10% TEA
H20
(mL) (mL) NH4OH (mL) (mL)
(mL)
20 mM NH4OH < 0.216 6.500 0.070 -- 3.214
30 mM NH4OH 0.216 6.500 0.105 -- 3.179
40 mM NH4OH 0.216 6.500 0.140 3.144
60 mM TEA 0.216 6.500 0.836 2.448
70 mM TEA 0.216 6.500 0.975 2.309
80 mM TEA 0.216 6.500 1.115 2.169
TABLE VI (Cont'd)
0.4% Peracetic Acid Generating Formula
Alkalinity Source DAMA DMF 7% H202 BI H20
(mL) (mL) (mL) (g) (mL)
5% DMF +90 mM
Benzimidazole 0.072 0.5 6.5 0.1065 , 2.780
IPA = isopropyl alcohol
BI = benzimidazole
DMF = dimethylformamide
DAMA = diacetylmethylamine
TEA = triethylamine
[0083] The inventive compositions have application in a wide variety of
uses. The
inventive compositions are useful as disinfectants/sterilants to clean floors,
countertops and other high-touch areas of hospitals or other health care
institutions.
They are also useful to clean various hard surfaces and equipment in
pharmaceutical
manufacturing facilities such as counters, floors, clean rooms, laboratories
and hard
surfaces in animal facilities.
[0084] Examples
[0085] Example 1 ¨ Efficacy
[0086] Sporicidal efficacy of the two-part liquid activator/formulated
hydrogen
peroxide system in a modified Non-Food Contact Sanitizer (NFCS) study is shown
in
FIG. 1. The results show that the inventive formulation, which generated
approximately 0.25% peracetic acid, was superior to bleach (1:10 dilution in
water)
against Bacillus subtilis, a known spore former, in the presence of various
organic
24
CA 02751123 2011-07-29
WO 2011/008225 PCT/US2010/000332
loads and varying contact times. Bacillus subtilis, ATCC 19659 is useful as a
surrogate for spore forming bacteria, such as anthrax, among others.
[0087] Example 2 ¨ Efficacy
[0088] Sporicidal efficacy of the inventive compositions was tested, using
the
Quantitative Carrier Test 2 (QCT-2) method against C.diff spores. The
inventive
composition shown in Table VII, below, was tested at various concentrations
and
mixed as indicated below.
TABLE VII
Dry TAED Activator
Ingredient Function Amount (wt.
Tetraacetylethylenediamine Active Ingredient 63.58%
(TAED)
Alkyldiphenyl Oxide Disulfonate Anionic Surfactant / Dispersant 11.49%
(Dowfax C1OL ¨ 45% active (aq))
Tetrasodium Iminodisuccinate Chelating Agent / Alkalinity Source 22.26%
Sodium Carbonate Alkalinity Source / Buffer 2.67%
Formulated Liquid Hydrogen Peroxide
Ingredient Function Concentration
35% Hydrogen Peroxide (aq) Active Ingredient 2.86%
Deionized Water 96.79%
Poloxamer 407 Nonionic Surfactant
0.05%
Fragrance Fragrance 0.30%
Dilutions:
To generate 0.050% peracetic acid, 0.225 grams of the dry TAED activator was
added to
200 mL of the formulated hydrogen peroxide.
To generate 0.075% peracetic acid, 0.337 grams of the dry TAED activator was
added to
200 mL of the formulated hydrogen peroxide.
To generate 0.100% peracetic acid, 0.449 grams of the dry TAED activator was
added to
200 mL of the formulated hydrogen peroxide.
To generate 0.125% peracetic acid, 0.562 grams of the dry TAED activator was
added to
200 mL of the formulated hydrogen peroxide.
CA 02751123 2011-07-29
WO 2011/008225
PCT/US2010/000332
To generate 0.150% peracetic acid, 0.674 grams of the dry TAED activator was
added to
200 mL of the formulated hydrogen peroxide.
To generate 0.175% peracetic acid, 0.786 grams of the dry TAED activator was
added to
200 mL of the formulated hydrogen peroxide.
To generate 0.200% peracetic acid, 0.898 grams of the dry TAED activator was
added to
200 mL of the formulated hydrogen peroxide.
To generate 0.250% peracetic acid, 1.123 grams of the dry TAED activator was
added to
200 mL of the formulated hydrogen peroxide.
[0089] PAA generated from the powdered activator/formulated liquid hydrogen
peroxide system, at various use concentrations, is shown in FIG. 2. FIG. 2
shows
average log reduction (cfu/carrier) for varying concentrations of PAA for a 3
minute
contact time. Results reflect excellent activity against C.diff spores for
peracetic acid
levels of greater than 0.075% at 3 minute contact time. Efficacy was
demonstrated
by a log reduction of greater than 5.
[0090] Example 3¨ Effect of Soil Load
[0091] The effect of organic soil load on average log reduction using QCT-2
testing was also evaluated. The formulation used is set forth in Table VIII
below.
TABLE VIII
Dry TAED Activator
Ingredient Function Amount
Tetraacetylethylenediamine (TAED) Active Ingredient 0.2757 grams
Alkyldiphenyl Oxide Disulfonate Anionic Surfactant / 0.0498 grams
(Dowfax C1OL ¨ 45% active (aq)) Dispersant
Tetrasodium lminodisuccinate Chelating Agent / Alkalinity 0.1107 grams
Source
Sodium Carbonate Alkalinity Source / Buffer 0.0133 grams
Polyvinyl Alcohol Film* Film Material 0.0792 grams
* PVA film was added to have the powder in a PVA water-soluble pouch that
dissolves upon "activation." Studies have shown it had no impact on efficacy
or
peracetic acid generation.
26
CA 02751123 2011-07-29
WO 2011/008225
PCT/US2010/000332
Formulated Liquid Hydrogen Peroxide
Ingredient Function Concentration (wt. %)
35% Hydrogen Peroxide (aq) Active Ingredient 2.86%
Deionized Water 96.79%
Poloxamer 407 Nonionic Surfactant 0.05%
Fragrance Fragrance 0.30%
The above powder composition was added to 200 mL of the formulated hydrogen
peroxide to form a solution containing about 0.075% PAA solution (-6% TAED).
[0092] Sporicidal efficacy of the powdered activator/formulated liquid
hydrogen
peroxide system against C.diff spores was not affected by the presence of soil
load.
As seen in FIG. 3, sporicidal efficacy of a 10% bleach solution against C.diff
spores
was greatly affected, whereas the effect of soil load on the inventive
formulations was
minimal.
[0093] Example 4 ¨ Effect of DAMA Formulations on Spores
[0094] The example formulas presented above in Table III were evaluated for
their
effectiveness in decontaminating materials contaminated with bacterial spores.
The
formulas produced peracetic acid, known to be a highly effective bactericide/
fungicide.
[0095] Specifically, a study was conducted to compare Formula A's ability
to kill
Bacillus subtilis spores in comparison to Clostridium sporogenes spores (FIG.
7).
The formula (see Table III) was found to be extremely effective in killing
spores of
both species.
[0096] Example 5¨ Effect of DAMA Formulation on Chemical Agents.
[0097] Peracetic acid is a known decontaminant for Mustard (HD), Nerve
(VX),
and Soman (GD) chemical warfare agents. The results of using inventive
formulas
E-I (Table IV) with these agents are shown in Table IX. The formulas were
reacted at
a 50:1 decontaminant to agent ratio. The reaction progress was checked at 15
minutes and reported. The addition of a pH modifier in Formula 1 was able to
increase the Soman (GD) activity.
27
CA 02751123 2012-11-30
Table IX
Efficacy of the Formulas Described in Table IV against Chemical Warfare Agents
Formula GD HD VX
16.2% 99.89% 48%
<1.0% 99.03% 46%
16.7% 100.00% 46%
6.9% 99.80% 43%
84.5% 55.95% 54%
[0098] Example 6 - Comparative Studies
[0099] A hard surface biological efficacy test was conducted on porcelain
penicylinders in order to compare its efficacy to 10% household bleach (0.5%
active).
Formula D (Table III) was found to be at least as effective as bleach (FIG.
5).
[00100] Several formulas were tested for their ability to kill bacterial
spores as
compared to a current commercially available sporicide (FIG. 6). Suspension
studies
were used to compare Formulations A, B and C (from Table III) to Spor-Klenz
Ready-To-Use Cold Sterilant.tpor-KlenzIs a product of STERIS Corporation and
is
currently one of the most effective sporicides on the market. All of the
inventive
formulations were found to be capable of demonstrating a 6.5 log reduction in
B.
subblis spores in 30 seconds, and yielded superior results as compared to the
Spor-
Klenz.
[00101] In accordance with the patent statutes, the best mode and preferred
embodiment have been set forth; the scope of the invention is not limited
thereto, but
rather by the scope of the attached claims.
* trade-mark
28
